Trials / Completed
CompletedNCT02944968
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
Clinical Study for Workflow and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System (the THERMOCOOL SMARTTOUCH® SF-5D Catheter With Temperature Sensing Capabilities and Micro Electrodes and CARTO 3 V 6.0 Technology) in Treatment of Patients With Paroxysmal Atrial Fibrillation (QDOT-Micro)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
Detailed description
The purpose of this study is to evaluate the workflow and acute performance , during standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro electrodes used in combination with the CARTO® 3 Navigation System with THERMOCOOL SMARTTOUCH® SF-5D-module.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THERMOCOOL SMARTTOUCH® SF-5D catheter |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-08-06
- Completion
- 2018-08-06
- First posted
- 2016-10-26
- Last updated
- 2025-02-04
- Results posted
- 2019-11-18
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02944968. Inclusion in this directory is not an endorsement.